• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to a method for coating the surface of the balloon of a balloon catheter with an active ingredient, the balloon being made of an elastic material and being expandable by being pressurized with a fluid, the balloon being intended to be expanded at a target location, the Coating of the surface of the balloon takes place at a pressure which is below the pressure which is used for the expansion of the balloon at the target location. In this way, due to the creation of shear forces, a particularly effective release of the active ingredient from the balloon onto the inner wall of the blood vessel or the surrounding tissue is achieved. The invention also relates to a corresponding balloon and a balloon catheter.
    公开号:CH715398B1
    申请号:CH00710/19
    申请日:2019-06-03
    公开日:2020-10-15
    发明作者:Ruebben Alexander
    申请人:Ruebben Alexander；
    IPC主号:
    专利说明:

    The invention relates to a method for coating the surface of the balloon of a balloon catheter with an active ingredient, wherein the balloon is made of an elastic material and is expandable by pressurization with a fluid, the balloon is intended to be expanded at a target location .
    The so-called "minimally invasive procedures" are becoming increasingly important in medicine. Percutaneous transluminal angioplasty (PTA) using balloon dilatation is often used to treat vascular constrictions such as arteriosclerosis. Here, a balloon catheter, which has a balloon expandable by the supply of fluid in the distal area, is brought to the stenosis (vasoconstriction) with the aid of a guide catheter. There, the balloon is expanded, as a result of which blood flow-inhibiting deposits are pressed onto or into the vessel wall, so that an undisturbed blood flow is possible again. After the treatment and the subsequent folding of the balloon, the balloon catheter is withdrawn from the vascular system and removed.
    In some cases, as a result of an initially successfully performed angioplasty, a renewed narrowing of the treated vascular section can occur. Such restenosis is mostly due to cell proliferation in the corresponding vascular segment, i. H. Cells of the blood vessel grow into the vessel lumen and in turn ensure that the blood flow is impeded. To prevent this, drug-coated balloon catheters are increasingly used. Corresponding drugs usually have a proliferation-inhibiting effect, particularly on the Smooth Muscle Cells (SMC) and are intended to prevent restenosis caused by excessive growth of these cells. The drug is located on the outside of the balloon and is transferred from the balloon to or into the inner wall of the vessel during balloon dilation.
    The balloon of the balloon catheter is typically coated by applying an active ingredient dissolved in a solvent to the surface of the balloon, the solvent evaporating after the solution has been applied. The active ingredient is then located as a layer on the surface and can be applied during balloon dilatation.
    The transfer of the active ingredient from the surface of the balloon to the inner wall of the vessel has proven to be problematic. It must be taken into account that the expansion of the balloon has to be limited in time, because occlusion of the blood vessel for too long periods of time would cause ischemia and an undersupply of the tissue or organs up to and including infarction. Accordingly, the active ingredient must be transferred within a comparatively short period of time. In the coronary area, the balloon can hold max. be expanded for a period of 30 to 60 s. Known drug-coated balloons, however, often require a longer period of time for adequate drug delivery. This leads either to the ischemic problems mentioned or to an inadequate release of the active substance due to the necessary shortening of the balloon expansion.
    Furthermore, it must be ensured that the active ingredient is only released from the balloon surface at the target location, especially since the active ingredients used are often toxic substances such as paclitaxel, which are undesirable for release away from the target location. In addition, the safety of the treating medical staff must be guaranteed. There is thus a conflict of objectives, on the one hand the active ingredient or the drug must be released as quickly as possible at the target location and transferred to the inner wall of the blood vessel, on the other hand the active ingredient should adhere as firmly as possible to the balloon during the preparation and advancement of the balloon catheter. As a rule, however, the release of a strongly adherent active ingredient occurs only slowly.
    [0007] The object is thus to provide a balloon which, on the one hand, securely holds the active substance coating, but on the other hand, quickly releases the active substance upon expansion at the destination.
    According to the invention, this object is achieved by a method for coating the surface of the balloon of a balloon catheter with an active ingredient, the balloon being made of an elastic material and being expandable by being pressurized with a fluid, the balloon being provided at a target location to be expanded, wherein the coating of the surface of the balloon takes place at a pressure which is below the pressure that is used for the expansion of the balloon at the target location.
    In the case of balloons for balloon catheters, a fundamental distinction must be made between non-compliant, semi-compliant and compliant balloons. The difference between the balloons lies in the different increase in diameter when the balloon is filled with a fluid under a certain pressure. The following is defined as compliance:Compliance (in%) = (d (high pressure) - d (low pressure)) / d (low pressure) × 100%, where d is the diameter of the balloon.
    The endpoints of the so-called working range can be viewed as high or low pressure, the working range extending between the nominal pressure at which the balloon reaches its nominal diameter and the maximum pressure to which the balloon can reach without damage can be brought. Depending on the percentage increase in diameter,<tb> <SEP> non-compliant balloons, diameter increase (compliance): 0 to 7%,<tb> <SEP> semi-compliant balloons, diameter increase (compliance): 5 to 10% and<tb> <SEP> compliant balloons, diameter increase (compliance): 10 to 500% differentiated.
    In the literature, different definitions can be found in part for the demarcation between non-compliant, semi-compliant and compliant, but it basically applies that the diameter of a compliant balloon increases significantly with the pressure, while the diameter of a non-compliant one Balloons remains almost constant even at high pressure. Non-compliant balloons are made from a largely inelastic material. With regard to the increase in diameter, semi-compliant balloons are between non-compliant and compliant balloons.
    There are sensible possible uses for all balloons. In addition, all balloons have certain advantages and disadvantages. Compliant balloons are more flexible and therefore easier to insert and are suitable for applications in which an adaptation to the shape of the vessel is desired, in the case of very advanced vascular constrictions and for pre-dilatation before the placement of a stent. A non-compliant balloon, on the other hand, is suitable if the balloon is to be brought to a certain diameter over its entire length, for example to push very firm, calcified vascular wall deposits outwards or to press an already placed stent firmly and evenly towards the vascular wall (Post Dilation). When pressed against vascular wall deposits, a non-compliant balloon exhibits an essentially cylindrical structure, while a semi-compliant or compliant balloon expands more proximally and distally to the deposit than in the area of the deposit for deposits that only extend over a short section itself. In this context, one speaks of the dog-bone effect.
    Since the balloon surface A in any case in the expanded balloon cylindrical area on the relationshipA = π × d × Lis related to the diameter d and the length L, the surface area, assuming a constant length of the balloon, increases to the same extent as the diameter, i.e. H. the definitions of compliance given above apply equally to the balloon surface. As far as the diameter of the balloon is mentioned in the context of this invention, this is always to be understood as the outer diameter.
    The invention relates to semi-compliant or compliant balloons, i.e. balloons. H. Balloons made of a material that has a certain elasticity. According to the invention, such a balloon is coated with an active substance when there is a slight application of pressure, while the pressure with which the balloon is expanded at the target location is higher. In the case of a balloon with a certain compliance, this leads to the diameter and thus also the balloon surface increasing. Since the pressure at the target location, at which the active ingredient applied to the balloon surface is to be released to the inner wall of the vessel, is higher than the pressure under which the balloon was coated with active ingredient, shear forces arise within the active ingredient layer. The active ingredient is therefore in any case partially blasted off from the balloon and detaches from the balloon. In this way, even strongly adhering coatings can be removed.
    [0015] The balloon catheters according to the invention can be used in blood vessels, in particular in the field of angioplasty. In this case, the balloon is targeted at a blood vessel. However, it is also possible to use balloon catheters in other medical fields. One possible use is in urology, where balloon catheters are inserted into the urinary bladder as urinary catheters. The catheter is fixed with the balloon. Here the balloon can e.g. B. be provided with a coating that prevents bacterial colonization and incrustation, for example with heparin.
    In pulmonology, balloon catheters can be used to expand or close a bronchus. Balloon catheters can also be used in gynecology. In the field of orthopedics, balloon catheters can be used to treat vertebral fractures by realigning the vertebrae by means of balloon expansion (balloon kyphoplasty). The balloon catheter according to the invention can in principle be used in all fields of medicine in which coated balloon catheters are used.
    According to the invention, balloons are preferably used in which the increase in diameter when the pressure is doubled, starting from the nominal pressure at which the balloon reaches its normal or nominal diameter, is at least 5%, preferably at least 10%, more preferably at least 20% particularly preferably at least 30%.
    The invention has the additional advantage that the peeling of the coating takes place only when the balloon expands, d. H. only at the destination where the active ingredient is actually to be transferred to the inner wall of the blood vessels, for example. In contrast, when the balloon is compressed, there is no detachment of the active ingredient; in other words, no active ingredient is released in areas of the blood vessel system that are not intended for this purpose. Likewise, there is no release or detachment of active ingredient outside the body, which could endanger people coming into contact with the balloon catheter.
    The expansion of the balloon is thus consciously exploited in order to transfer active ingredient from the balloon, in particular to an inner wall of the blood vessel. In order to achieve a uniform coating of the balloon, the pressure that acts on the balloon and at which the coating is carried out should be so high that the balloon unfolds completely or at least largely, but lower than the pressure with which the balloon is typically applied at the target location in the blood vessel. For example, a balloon can be coated when the pressure is applied to 3 bar, while the pressure applied in the blood vessel is 6 bar. The diameter of a compliant balloon can be, for. B. increase from 4.5 mm to 6 mm, this means an increase in the diameter and thus also the balloon surface by 33%. This causes a strong shear force that causes the active ingredient to break off.
    The pressure at which the coating takes place is advantageously at least 20%, more preferably at least 30% below the pressure that is used for the expansion of the balloon at the target location. The pressure at which the coating takes place is also advantageously max. 50% of the pressure used to expand the balloon at the target location. The increase in the balloon surface between the coating process and the expansion process at the target location should be at least 10%, advantageously at least 20%, further advantageously at least 30%, further advantageously at least 40% and further advantageously at least 50%.
    In order to ensure the expansion capability on which the invention is based, the balloon is at least partially made of an elastic material. As an elastic material, for. B. a polyurethane, a polyolefin copolymer, a polyethylene or a silicone can be used. Other materials that can be used are thermoplastic elastomers, in particular polyether block amides (PEBA). This is a thermoplastic elastomer that can be obtained by polycondensation of a carboxylic acid polyamide with a polyether with terminal OH groups. In particular, PEBA is sold under the name PEBAX <®> by the company Arkema. Polyamides such as nylon (polyhexamethylene adipamide) with a certain elasticity can also be used at least for semi-compliant balloons.
    Alternatively, other polyamides can also be used as elastic material for the balloon, for example those such as those sold by EMS-GRIVORY under the name Grilamid <®>. The use of a polyamide 12 (PA 12, Grilamid <®> L), a polyamide obtainable by the polycondensation of laurolactam, is particularly preferred. Other polyamides that can be used are polyamide 10.10 (PA 10.10, Grilamid <®> 1S), a polyamide obtainable by polycondensation of decanediamine and sebacic acid, polyamide 6.10 (PA 6.10, Grilamid <®> 2S), a polyamide obtainable by polycondensation of hexamethylenediamine and sebacic acid, or Polyamide 6.12 (PA 6.12, Grilamid <®> 2D), a polyamide obtainable by polycondensation of hexamethylenediamine and dodecanedioic acid.
    The active ingredient used is, in particular, a drug or medicament, preferably a drug that has a proliferation-inhibiting effect and prevents the vasoconstricting overgrowth of the area enlarged by the balloon. It can also be a hormone-like or regulating active ingredient that can influence organ-specific effects or regulatory functions on certain cells. In particular, the active ingredient can be selected from: tretinoin, orphan receptor agonists, elena derivatives, corticosteroids, steroid hormones, paclitaxel, rapamycin, tacrolimus, hydrophobic proteins and substances that change cell proliferation. It is also possible to use mixtures of these active ingredients. In addition, it is also possible to use derivatives of the active substances mentioned, whereby derivatives are understood to mean in particular salts, esters and amides. Methylprednisolone, dexamethasone or estradiol, for example, can be used as steroid hormones. The use of paclitaxel, rapamycin or tacrolimus or corresponding derivatives is particularly preferred.
    In general, however, the term active ingredient is to be understood broadly, d. H. it can in principle be any coating on the balloon of the balloon catheter with which a certain effect is to be achieved at the target location. When introduced into blood vessels, this effect can consist in particular of inhibiting cell proliferation. In other areas of medicine, however, the desired effect can be different, for example in the area of urology for urinary catheters, where the coating is intended, in particular, to inhibit bacterial colonization. Here, for example, heparin can be used as an active ingredient.
    The coating of the surface of the balloon with the active ingredient is typically carried out in that the surface of the balloon is brought into contact with a solution of the active ingredient. This can be done in particular by immersing the balloon in the solution. Immersion usually takes a max. 1 min, typically 10 to 30 s. After immersion, the balloon should be withdrawn from the first solution at a speed of up to 10 mm / s. It is even more favorable if the extraction takes place at a speed of less than 5 mm / s, preferably at a speed between 0.5 mm / s and 2 mm / s. Slowly pulling it out results in slow drying of the surface.
    Before coating the balloon, it is useful to clean the surface of the balloon. This can be done, for example, with an appropriate solvent, for example the solvent also used for applying the active ingredient.
    The solution can be saturated with respect to the active ingredient, but this is not absolutely necessary. For example, methylene chloride, chloroform, alcohol, in particular ethanol, methanol or isopropanol, acetone, diethyl ether, liquid hydrocarbons such as pentane, hexane, heptane, cyclohexane or octane, toluene, tetrahydrofuran (THF) or ethyl acetate can be used as solvents. The use of solvent mixtures is also possible. It is preferably a solution of the active ingredient in methylene chloride.
    As an alternative to coating by dipping, this can also be done in other ways, for example by spraying.
    When the balloon catheter according to the invention is used, it is introduced into the blood vessel system or another body lumen and pressed against the inner wall of the vessel / lumen by being inflated. A large part of the coating is transferred to the inner wall. After the pressure has been released and the balloon catheter has been removed from the vascular system / lumen, the active substance applied within the coating gradually penetrates the tissue.
    Under balloon within the meaning of the invention, the element of a balloon catheter that can be expanded by supplying a fluid is understood, regardless of the shape of the expandable element or of what material it is made of. The fluid can be gaseous or liquid. A gas, for example air, is preferred. The pressure applied to the balloon for expansion in the blood vessel / lumen is typically between 5 and 15 bar. The dimensions of the balloon can differ greatly depending on the area of application, the diameter in the expanded state can for example be between approx. 1 and approx. 50 mm, the length between approx. 5 and approx. 300 mm. Possibly. However, the dimensions can also deviate from this, for example when using the balloon / balloon catheter in urology or veterinary medicine.
    Balloon catheters are generally well known in the prior art and have an elongated catheter running from proximal to distal and a balloon arranged in the distal area. It is a catheter whose dimensions are matched to the introduction into a body lumen, in particular a (blood) vascular system. The exact dimensions can vary, depending on whether the blood vessel is, for example, a coronary artery, an intracranial blood vessel or a lower leg artery. In addition, the balloon catheter has means for supplying a fluid to the balloon. This can be a delivery lumen that extends the length of the balloon catheter.
    In addition, the balloon catheter according to the invention can serve not only to eliminate stenoses and the local introduction of active substance, but also to place a stent (endoprosthesis) in the body lumen. Stents are tubular support structures that are implanted in a body lumen, for example a blood vessel, in order to keep this permanently open. Such stents can be self-expanding or can be expanded with the aid of a balloon. For this purpose, the stent is crimped onto the balloon and inserted into the body lumen with the aid of the balloon catheter. At the intended location, the balloon is then expanded by supplying a fluid, as a result of which the stent also expands and is anchored in the body lumen. At the same time, when the balloon according to the invention is used, the active substance is released onto the wall of the body lumen. Finally, the balloon is contracted again and removed from the body lumen while the stent remains in the body lumen.
    According to a preferred embodiment, at least the part of the surface of the balloon coated with the active substance is wetted with a liquid containing water and / or at least one alcohol. When the surface of the balloon is coated with an active ingredient, a lacquer-like, transparent active ingredient layer is usually produced on the surface, which serves as the basis for a homogeneous and reproducible active ingredient loading. This coating is attacked by the liquid containing water and / or at least one alcohol and the surface becomes more porous or partially embrittled. The entire coating becomes more brittle and optically less transparent, i.e. more milky. The surface produced in this way has a chalk-like, possibly also non-crystalline consistency, which enables a greater amount of active substance to be removed when there is friction than in the case of a coating simply by wetting the surface of the balloon with a solution of the active substance. A corresponding method is basically known from WO 2013/178820 A1.
    [0034] The liquid containing water and / or at least one alcohol is in particular an aqueous solution containing an alcohol and / or a ketone. The concentration of the alcohol and / or ketone in the aqueous solution is typically 10 to 70% (v / v), preferably 30 to 65% (v / v), more preferably 50 to 60% (v / v) and very particularly preferably approx. 55% (v / v). In principle, water-miscible alcohols and ketones can be used, it also being possible to use a mixture of several alcohols and / or ketones, for which the above-mentioned preferred concentration data then apply overall. The use of ethanol, methanol, acetone and / or isopropanol is preferred. Most preferred is ethanol. Furthermore, the aqueous solution can comprise an azeotropic solvent mixture, in particular an alcohol / water mixture, preferably an ethanol / water mixture. It would also be conceivable to provide an additional amount of active ingredient in the liquid containing water and / or at least one alcohol in order to increase the loading of the balloon with active ingredient.
    According to a further advantageous embodiment of the invention, at least the part of the surface of the balloon coated with the active ingredient is coated with a polysaccharide before or after the coating with the active ingredient. It is also possible to first coat with active ingredient, then coat with a polysaccharide and finally again with active ingredient. It has surprisingly been found that the polysaccharide coating acts like an adhesive on the inner wall of the treated vessel, i. H. the active ingredient adheres much better to the vessel wall and is less easily carried away by the bloodstream. Accordingly, the active ingredient can develop its effect over a long period of time and gradually get from the polysaccharide coating into the tissue of the vessel. It could be shown that even after a few weeks significant concentrations of the active substance can still be detected.
    Polysaccharides represent a hydrophilic coating that experiences a certain swelling or softening in an aqueous environment such as blood. As a result, the active ingredient is transferred well to the inner wall of the vessel during balloon dilatation. The method according to the invention is particularly suitable for applying lipophilic coatings to the balloon. It has been found that the hydrophilic polysaccharides are particularly well suited to ensure that lipophilic active ingredients are effectively transferred to the inner walls of the treated vessels during balloon dilation and cause a long-lasting concentration of active ingredients.
    When the polysaccharide is coated, it is also preferably present in a solution, preferably in an alcoholic solution. In addition to one or more alcohols, this can in particular also contain water. An aqueous-alcoholic solution is advantageous in that it dissolves the polysaccharide well, but does not remove a previously applied layer of active ingredient. In addition, the organic content in the solution ensures rapid drying after wetting. The concentration of the alcohol or alcohols in the further solution is typically 10 to 70% (v / v), preferably 30 to 65% (v / v), more preferably 50 to 60% (v / v) and particularly preferably approx 55% (v / v). Those alcohols which dissolve the polysaccharide can be used as alcohol. As a rule, such alcohols are also miscible with water. Ethanol, methanol and isopropanol are preferred, and ethanol is particularly preferred.
    The mean molar mass of the polysaccharide is expediently 10,000 to 100,000,000 Da. An average molar mass between 20,000 and 80,000 Da has proven to be particularly useful. The polysaccharide content of the further solution is preferably 1 to 15% by weight, more preferably 2 to 10% by weight and particularly preferably 3 to 8% by weight.
    [0039] The polysaccharide is preferably a branched polysaccharide. Mixtures of several polysaccharides and modified polysaccharides are also suitable. Dextrans, in particular natural dextrans, are preferred. Dextrans are high molecular weight, branched polymers that are composed of glucose units. You will u. a. produced by bacteria of the genus Leuconostoc. They are used as blood plasma substitutes or as carriers in chromatography.
    The dextran can in particular be a natural dextran. Dextran 40 with an average molar mass of approximately 40,000 Da is particularly preferred. In addition to dextrans, however, other polysaccharides can in principle also be used. An example of a modified polysaccharide that can be used is hydroxyethyl starch (HES).
    In principle, both the entire balloon surface or only a part of the balloon surface, for example the area of the surface which comes into contact with the tissue during expansion, can be coated with the method according to the invention. In particular, the balloon can comprise a cylindrical area and at least one conical area. In this case, for example, only the cylindrical area of the balloon can be coated according to the invention with an active ingredient or the cylindrical area of the balloon and a conical area.
    The wetting or coating of the surface of the balloon with a liquid containing water and / or at least one alcohol or the liquid containing a polysaccharide can be done by immersing the balloon in the liquid, similar to the previously described coating with the active ingredient. It makes sense to also carry out this wetting at the pressure at which the coating with the active substance also takes place, in order to ensure a uniform detachment of the coating with greater expansion of the balloon at the target location in the blood vessel. In this context, an identical pressure is also regarded as a pressure which differs slightly from the pressure at which the coating with active ingredient is carried out, provided that the balloon diameter largely corresponds. As an alternative to wetting by immersion, wetting can also take place in another way, for example by spraying. A drying step is useful after the individual coating steps. In the case of volatile solvents, drying may take place immediately; in the case of other solvents, drying can be supported by setting the balloon in rotation or by a stream of air.
    In principle, certain coating steps can also be repeated. For example, it is possible to bring the balloon into contact with an active ingredient solution several times in order to increase the active ingredient loading. Possibly. it is also possible to apply different active ingredients in this context.
    In addition to the method according to the invention, the invention also relates to a balloon with a coating as can be achieved by the method described. This is characterized by the fact that, when the balloon expands beyond the expansion of the balloon at which the coating took place, strong shear forces act, which cause the coating to flake off and thus release it from the balloon surface to the inner wall of the blood vessel and the surrounding tissue . The invention also relates to a balloon catheter with such a balloon. The balloon catheters can, depending on their dimensions, be used in a wide variety of areas of the blood vessel system, namely in particular in the coronary, intracranial and peripheral areas.
    The balloon catheter according to the invention typically has lumens, preferably at least two lumens, one lumen being used for fluid supply and pressurization and being connected to the interior of the balloon, while the other lumen is used to receive a guide wire which is first pushed forward to the target location then bring the balloon catheter over the guide wire to the target site. In this context, two different systems are essentially known from the prior art, namely over-the-wire (OTW) and rapid exchange (Rx) balloon catheters. The balloon catheter according to the invention can be in the form of both an OTW and an Rx balloon catheter. While in an OTW catheter the lumen for the guide wire extends over the entire length of the catheter from proximal to distal, the Rx catheter has a separate feed opening for the guide wire (Rx port), where the guide wire is clearly distal to the proximal End of the catheter emerges from the catheter. Correspondingly, in the case of an OTW balloon catheter, the lumens for the fluid supply and the guide wire run concentrically or parallel to one another from the proximal end of the catheter to the balloon, whereas in an Rx catheter this is only the case between the Rx port and the balloon. The section between the Rx port and the proximal end, however, has only one lumen for the fluid supply. Typically, the lumens are concentric in the areas where the catheter has two lumens, i.e. H. the narrower inner lumen for the guide wire runs through the further outer lumen for the fluid supply.
    A so-called catheter hub is usually provided at the proximal end of the balloon catheter, d. H. a connector for the device for fluid supply and pressurization. The connection can e.g. B. be a conventional Luer or Luer lock connection. Under proximal is directed towards the exterior of the body, i.e. H. towards the attending physician, distal means the opposite direction, d. H. in the direction of the blood vessel to be treated. The balloon catheter is usually introduced into the human body in the groin area via the femoral artery.
    Radiopaque markings, which are used to visualize the catheter in the X-ray image, can be attached at various positions along the balloon catheter. In particular, these can be markings made of platinum or a platinum alloy.
    example
    A balloon made of an elastic polyurethane is subjected to a pressure of 3 bar from the inside. At this pressure the balloon has a diameter of 4.5 mm. In this state, the balloon is immersed in a solution of paclitaxel in methylene chloride and slowly withdrawn again.
    The concentration of paclitaxel is 200 mg / ml. The coating takes place at room temperature. The pressure is then released, whereupon the balloon folds up tightly.
    The balloon is part of a balloon catheter that is inserted into the human body and advanced through the blood vessel system to the target location. There is a pressurization of 6 bar. At this pressure the diameter is 6 mm, i. H. The diameter and surface area have increased by 33% compared to the coating step. This causes strong shear forces to develop and the layer of active substance that is released onto the inner wall of the vessel bursts off.
    权利要求:
    Claims (14)
    [1]
    1. A method for coating the surface of the balloon of a balloon catheter with an active ingredient, wherein the balloon is made of an elastic material and is expandable by the application of pressure with a fluid, wherein the balloon is intended to be expanded at a target location, characterized in that the surface of the balloon is coated at a pressure that is below the pressure that is used for the expansion of the balloon at the target location.
    [2]
    2. The method according to claim 1, characterized in that the pressure at which the coating takes place is at least 20%, preferably at least 30% below the pressure that is used for the expansion of the balloon at the target location.
    [3]
    3. The method according to claim 2, characterized in that the pressure at which the coating takes place is a maximum of 50% of the pressure that is used for the expansion of the balloon at the destination.
    [4]
    4. The method according to any one of claims 1 to 3, characterized in that the elastic material comprises a polyurethane, a polyolefin copolymer, a polyethylene or a silicone.
    [5]
    5. The method according to any one of claims 1 to 3, characterized in that the elastic material comprises a thermoplastic elastomer, in particular a polyether block amide.
    [6]
    6. The method according to any one of claims 1 to 5, characterized in that the increase in the diameter of the balloon when the pressure is doubled, starting from the nominal pressure at which the balloon reaches its nominal diameter, at least 5%, preferably at least 10%, more preferably is at least 20% and particularly preferably at least 30%.
    [7]
    7. The method according to any one of claims 1 to 6, characterized in that the active ingredient used is selected from the group: tretinoin, orphan receptor agonists, egg derivatives, corticosteroids, steroid hormones, paclitaxel, rapamycin, tacrolimus, hydrophobic proteins, heparin, hormone-like substances, and cell proliferation modifiers Substances.
    [8]
    8. The method according to any one of claims 1 to 7, characterized in that at least the part of the surface of the balloon coated with the active ingredient is wetted with a liquid containing water and / or at least one alcohol after coating with the active ingredient.
    [9]
    9. The method according to any one of claims 1 to 8, characterized in that at least the part of the surface of the balloon coated with the active ingredient was coated with a polysaccharide before coating with the active ingredient and / or coated with a polysaccharide after coating with the active ingredient becomes.
    [10]
    10. The method according to claim 9, characterized in that the mean molar mass of the polysaccharide is 10,000 to 100,000,000 Da.
    [11]
    11. The method according to claim 10, characterized in that the mean molar mass of the polysaccharide is 20,000 to 80,000 Da.
    [12]
    12. The method according to any one of claims 9 to 11, characterized in that the polysaccharide is a dextran.
    [13]
    13. Balloon of a balloon catheter, the surface of which has at least partially a coating with an active ingredient, obtained by a method according to one of claims 1 to 12.
    [14]
    14. Balloon catheter comprising a balloon according to claim 13.
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    TR201808332T4|2010-12-04|2018-07-23|Aachen Scient International Pte Ltd|SURFACE COATING AND COATING METHOD FOR A BALLOON CATHETER BALLOON, BALLOONED BALLOON CATHETER WITH ORDERED COATING|
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE102018123050.8A|DE102018123050B4|2018-09-19|2018-09-19|Active ingredient coating for balloons of balloon catheters|
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